Systems for medical device interactions

ABSTRACT

An external wearable medical device includes an electrode to detect patient cardiac activity; a therapy electrode to provide a therapy in response to detecting an arrhythmia event; a GUI display comprising a caregiver interface and a patient interface; and a processor configured to provide, to the caregiver interface, a first set of information that includes information for operating the device in conjunction with the patient and an alert history of the device including an indication of one or more detected arrhythmia events, provide, to the patient interface, a second set of information that includes information for allowing the patient to cause the device to suspend providing the therapy and a direction to the patient to contact a caregiver responsive to detecting an event affecting at least one of the device and the patient, and responsive to detecting the event, automatically transmitting a notification of the event to an external entity.

RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. § 120 as acontinuation of U.S. application Ser. No. 15/217,132, filed Jul. 22,2016, titled SYSTEMS FOR MEDICAL DEVICE INTERACTIONS, which claimspriority under 35 U.S.C. § 119(e) to U.S. Provisional Application Ser.No. 62/195,696, filed Jul. 22, 2015, titled MEDICAL DEVICE INTERACTIONS,each of which is hereby incorporated herein by reference in its entiretyfor all purposes.

BACKGROUND Technical Field

This disclosure relates to systems and techniques for facilitating humaninteractions with medical devices, in particular caregiver and patientinteractions with external medical devices.

Discussion

There are a wide variety of electronic and mechanical devices formonitoring and treating patients' medical conditions. In some examples,depending on the underlying medical condition being monitored ortreated, medical devices such as cardiac pacemakers or defibrillatorsmay be surgically implanted or connected externally to the patient. Insome cases, physicians may use medical devices alone or in combinationwith drug therapies to treat patient medical conditions.

One of the most deadly cardiac arrhythmias is ventricular fibrillation,which occurs when normal, regular electrical impulses are replaced byirregular and rapid impulses, causing the heart muscle to stop normalcontractions and to begin to quiver. Normal blood flow ceases, and organdamage or death can result in minutes if normal heart contractions arenot restored. Because the victim has no perceptible warning of theimpending fibrillation, death often occurs before the necessary medicalassistance can arrive. Other cardiac arrhythmias can include excessivelyslow heart rates known as bradycardia.

Implantable or external pacemakers and defibrillators (such as automatedexternal defibrillators or AEDs) have significantly improved the abilityto treat these otherwise life-threatening conditions. Such devicesoperate by applying corrective electrical pulses directly to thepatient's heart. For example, bradycardia can be corrected through theuse of an implanted or external pacemaker device. Ventricularfibrillation can be treated by an implanted or external defibrillator.

For example, certain medical devices operate by continuously orsubstantially continuously monitoring the patient's heart through one ormore sensing electrodes for treatable arrhythmias and, when such isdetected, the device applies corrective electrical pulses directly tothe heart through one or more therapy electrodes.

SUMMARY

According to at least one aspect, an external medical device isprovided. The external medical device includes one or more electrodesconfigured to detect a cardiac activity of the patient, a treatmentcomponent configured to provide a therapy to the patient based at leastin part on the cardiac activity detected by the electrodes, a userinterface including at least one caregiver interface and at least onepatient interface, and a processor in communication with the userinterface. The processor may be configured to a first set of informationto the caregiver interface and a second set of information to thepatient interface. In some examples, the first set of informationincludes information for operating the external medical device inconjunction with the patient and the second set of information includesinformation for allowing the patient to cause the external medicaldevice to suspend providing the therapy to the patient.

In some examples, the first set of information includes a notificationincluding a direction to the caregiver to administer at least onetraining module to the patient. In some examples, the first set ofinformation includes device-guided instructions for setting up thedevice for use in conjunction with the patient.

In some examples, the processor is further configured to cause the userinterface to prompt for security credentials before providing access tothe caregiver interface. In some examples, the second set of informationfurther includes a notification including a direction to the patient tocontact a healthcare provider responsive to detecting an event.

In some examples, the first and second sets of information includes atleast one of notifications, instructions, directions, prompts, messages,alerts, device status information, and patient-related information. Insome examples, the first and second information can be provided throughat least one of a visual, audible, tactile, or Braille output component.

According to at least one aspect, an external medical device isprovided. The external medical device includes a sensing componentconfigured to attach to a patient and detect a cardiac activity of thepatient, a treatment component configured to provide a therapy to thepatient based at least in part on the detected cardiac activity of thepatient from the sensing component, and a controller including an outputcomponent. The controller may be configured to provide access to atleast one training module relating to an operation of the externalmedical device and provide a notification via the output component toadminister the at least one training module.

In some examples, the sensing component is configured to detect at leastone of ECG activity, tissue fluid, lung fluid, lung sounds, heartsounds, and patient activity. In some examples, the treatment componentincludes a therapy electrode for providing at least one of adefibrillating, pacing and transcutaneous electrical nerve stimulation(TENS) therapy to the patient. In some examples, the notificationincludes direction to a caregiver to administer the at least onetraining module to the patient.

In some examples, the notification includes direction to a caregiver toreview the at least one training module. In some examples, thenotification includes direction to the patient to review the at leastone training module.

In some examples, the at least one output component includes a displayand wherein the controller provides the notification via the display. Insome examples, the at least one output component includes a visualindicator and wherein the controller provides the notification via thevisual indicator. In some examples, the at least one output componentincludes a speaker, and wherein the controller provides the notificationas an audible alert via the speaker.

In some examples, the at least one training module includes at least oneof: a bystander training module, a patient training module, and acaregiver training module. In some examples, the at least one trainingmodule includes at least one of: a response button training module, agarment training module, and a device action training module.

In some examples, the controller provides the notification responsive todetecting an event. The event may include, for example, at least one of:connecting the sensing component to the controller, initiation ofcommunication between the sensing component and the controller,connecting a battery to the controller, a predetermined period of timeelapsing, detecting that the at least training module has not beenaccessed, and fitting the external medical device to a patient. In atleast one example, the event of fitting the external medical device to apatient may include causing the device to enter a new patient mode.

In some examples, the controller monitors a completion status of the atleast one training module and provides the notification in response tothe completion status.

In some examples, the at least one training module includes a pluralityof sections and the controller suppresses the notification responsive toa predetermined minimum number of sections of the plurality of sectionsbeing completed. The controller may be configured to monitor a durationof access of each section of the plurality of sections and identify therespective each section of the plurality of sections as completeresponsive to the duration of access exceeding a second completionthreshold.

In some examples, the controller is configured to monitor a duration ofaccess of the at least one training module and identify the at least onetraining module as incomplete responsive to the duration of access tothe at least one training module being below a module completionthreshold. In some examples, the controller includes a networkinterface, the controller configured to transmit a message to anexternal system via the network interface, the message relating to atleast one of the patient and the external medical device.

In some examples, the controller includes at least one input device, thecontroller configured to override the notification responsive toreceiving user input via the at least one input device. In someexamples, the at least one input device includes at least one of a touchscreen and a keypad, and wherein the user input includes one or moresecurity credentials.

In some examples, the controller is configured to send a signal to anexternal system in response to providing the notification. In someexamples, the notification includes a training access feature configuredto, responsive to user input, provide access to the at least onetraining module. In some examples, the external medical device isconfigured to attach to the patient via adhesive electrodes. In someexamples, the external medical device is configured for long termattachment to the patient.

In some examples, the sensing component is configured for long termmonitoring of the patient. In some examples, the external medical deviceis configured for substantially continuous attachment to the patient. Insome examples, the sensing component is configured for substantiallycontinuous monitoring of the patient.

According to at least one aspect, an external medical device isprovided. The external medical device includes a plurality of electrodesconfigured to attach to a patient, the plurality of electrodes includingat least one cardiac sensing electrode and at least one therapyelectrode and a controller unit coupled to the plurality of electrodesand including at least one output device. The controller unit may beconfigured to administer at least one training module and provide anotification via the at least one output device, the notificationincluding a direction to a caregiver to administer the at least onetraining module to the patient.

In some examples, the at least one output device includes a display andwherein the controller unit is configured to provide the notification tothe caregiver via the display. In some examples, the at least onetraining module includes at least one of: a pacing training module, adefibrillation training module, and an arrhythmia detection trainingmodule.

In some examples, the controller unit is configured to provide thenotification responsive to detecting an event. The event may include,for example, at least one of: connecting the plurality of electrodes tothe controller unit, connecting a battery to the controller unit, apredetermined period of time elapsing, and fitting the external medicaldevice to a new patient.

In some examples, the controller unit is configured to monitor acompletion status of the at least one training module and provide thenotification to the caregiver responsive to the completion status of theat least one training module being incomplete.

In some examples, the at least one training module includes a pluralityof sections and wherein the controller unit is configured to suppressthe notification to the health care provider responsive to a minimumnumber of sections of the plurality of sections being completed. Thecontroller unit may be configured to monitor a duration of access ofeach section of the plurality of sections and identify the respectivesection as complete responsive to the duration of access to therespective section exceeding a threshold.

In some examples, the controller unit is configured to monitor aduration of access of the at least one training module and determinethat the administration of the at least one training module was rushedresponsive to the duration of access to the at least one training modulebeing below a threshold. The controller unit may include a networkinterface and is configured to transmit a message to an external systemvia the network interface indicating that the administration of the atleast one training module was rushed.

In some examples, the controller unit includes at least one input deviceand wherein the controller unit is configured to override thenotification responsive to receiving input from the caregiver via the atleast one input device. The at least one input device may include, forexample, at least one of a touch screen and a keypad and wherein theinput from the caregiver includes one or more security credentials.

In some examples, the external medical device is a hospital worn deviceand wherein the caregiver includes a trained medical service provider.The trained medical service provider may include, for example, at leastone of a nurse, a physician assistant, and a doctor.

According to at least one aspect, a patient monitoring device isprovided. The patient monitoring device includes a sensing componentconfigured to attach to a patient and detect one or more parametersrelating to the patient and a controller including an output component.The controller may be configured to administer at least one trainingmodule and provide a notification via the output component to administerthe at least one training module. It is appreciated that the sensingcomponent, in some examples, may be configured to detect cardiacactivity of the patient.

According to at least one aspect, an external medical device isprovided. The external medical device includes a plurality of electrodesconfigured to attach to a patient including at least one cardiac sensingelectrode and at least one therapy electrode and a controller incommunication with the plurality of electrodes. The controller may beconfigured to detect an event associated with at least one of theexternal medical device and the patient and provide a notification viaat least one output component, the notification including a direction tothe patient to contact a caregiver.

In some examples, the controller unit includes at least one responsemechanism and the controller detects an arrhythmia of the patient,instructs the patient to operate the at least one response mechanism,and provides the notification to the patient to contact the caregiverresponsive to operation of the at least one response mechanism. Thecontroller may, for example, delay treatment to the patient via the atleast one therapy electrode and provides a notification to the patientthat treatment is being delayed responsive to operation of the at leastone response mechanism. In some examples, the at least one outputcomponent includes a display and the controller unit may, for example,alternate between displaying a notification to the patient to contactthe caregiver and displaying a notification to the patient thattreatment is being delayed.

In some examples, the at least one output component includes a displayand wherein the controller unit displays a notification to the patientto contact the caregiver.

In some examples, the controller unit detects at least one malfunctionof the external medical device and provides a notification to thepatient to contact the caregiver responsive to detecting the at leastone malfunction. The at least one malfunction may include, for example,at least one of electrode falloff, excessive noise, and low battery.

In some examples, the controller unit automatically contacts thecaregiver responsive to operation of the at least one responsemechanism. In some examples, the controller unit automatically contactsthe caregiver responsive to detection of an arrhythmia.

In some examples, the external medical device is a hospital worn deviceand wherein the caregiver includes a trained medical service provider.The trained medical service provider may include, for example, at leastone of a nurse, a physician assistant, and a doctor.

Other features and advantages of the invention will be apparent from thedrawings, detailed description, and claims. Moreover, it is to beunderstood that both the foregoing information and the followingdetailed description are merely illustrative examples of variousaspects, and are intended to provide an overview or framework forunderstanding the nature and character of the claimed subject matter.Any example disclosed herein may be combined with any other example.References to “an example,” “some examples,” “an alternate example,”“various examples,” “one example,” “at least one example,” “this andother examples” or the like are not necessarily mutually exclusive andare intended to indicate that a particular feature, structure, orcharacteristic described in connection with the example may be includedin at least one example. The appearance of such terms herein is notnecessarily all referring to the same example.

Furthermore, in the event of inconsistent usages of terms between thisdocument and documents incorporated herein by reference, the term usagein the incorporated references is supplementary to that of thisdocument; for irreconcilable inconsistencies, the term usage in thisdocument controls. In addition, the accompanying drawings are includedto provide illustration and a further understanding of the variousaspects and examples, and are incorporated in and constitute a part ofthis specification. The drawings, together with the remainder of thespecification, serve to explain principles and operations of thedescribed and claimed aspects and examples.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings are not intended to be drawn to scale. In thedrawings, components that are identical or nearly identical may berepresented by a like numeral. For purposes of clarity, not everycomponent is labeled in every drawing. In the drawings:

FIG. 1 shows an example wearable defibrillator;

FIGS. 2A and 2B show an example medical device controller;

FIG. 3 shows a block diagram of an example medical device controller;

FIG. 4 shows an example medical device controller in communication withan example base station;

FIG. 5 shows an example medical device for monitoring and treatmentpatients in a healthcare facility;

FIGS. 6A and 6B show an example set of screens for patient setup on amedical device;

FIGS. 7A-7D show an example set of screens for configuring and operatinga medical device;

FIGS. 8A and 8B show example procedures for accessing various caregiverinformation;

FIGS. 9A-9C show an example set of screens for a caregiver to administertraining to a patient;

FIG. 10 shows an example process for reminding a caregiver to administertraining to a patient;

FIGS. 11A-11C show example alert messages displayed by a medical devicein response to various events; and

FIGS. 12A and 12B shows an example set of screens to manage the alertson the medical device.

FIG. 13 shows an example set of screens to manage device servicereminders.

DETAILED DESCRIPTION

Systems and techniques as disclosed herein are provided to facilitateand manage human interactions with medical devices. For example, medicaldevices as disclosed herein may be cardiac devices that monitor one ormore cardiac signals of a patient. For example, such medical devices canbe configured to determine whether the patient may be experiencing acardiac condition. The medical devices can include a plurality ofsensing electrodes that are disposed at one or more locations of thepatient's body and configured to detect or monitor the cardiac signalsof the patient. In some implementations, the medical device can beconfigured to monitor, in addition to cardiac signals, otherphysiological parameters as described in further detail below. Forexample, such devices can be used as cardiac monitors in certain cardiacmonitoring applications, such as mobile cardiac telemetry (MCT) and/orcontinuous event monitoring (CEM) applications.

In some implementations, a medical device as disclosed herein can beconfigured to determine an appropriate treatment for the patient basedon the detected cardiac signals (and/or other physiological parameters)and cause one or more therapeutic shocks (e.g., defibrillating and/orpacing shocks) to be delivered to the body of the patient as describedin further detail below. Accordingly, the medical device can include oneor more therapy electrodes that are disposed at one or more locations ofthe patient's body and configured to deliver the therapeutic shocks.

A medical device as described herein can be configured to monitor apatient for a cardiac arrhythmia condition such as bradycardia,ventricular tachycardia (VT) or ventricular fibrillation (VF). Inaddition, while the detection methods and systems described hereinafterare disclosed as detecting VT and VF, this is not to be construed aslimiting the invention as other arrhythmias, such as, but not limitedto, atrial arrhythmias such as premature atrial contractions (PACs),multifocal atrial tachycardia, atrial flutter, and atrial fibrillation,supraventricular tachycardia (SVT), junctional arrhythmias, tachycardia,junctional rhythm, junctional tachycardia, premature junctionalcontraction, and ventrical arrhythmias such as premature ventricularcontractions (PVCs) and accelerated idioventricular rhythm, may also bedetected. In the case of treatment devices, such as, pacing and/ordefibrillating devices, if an arrhythmia condition is detected, thedevice can automatically provide a pacing, defibrillation, and/ortranscutaneous electrical nerve stimulation (TENS) pulses or shocks, asneeded, to treat the condition.

Aspects of the present disclosure manifest an appreciation for variouschallenges in deploying a medical device in a busy hospital environment.For example, a single medical device may be used on multiple patients insuccession and require a caregiver (e.g., a nurse or other medicalpractitioner) to setup and/or configure the medical device for eachpatient that is prescribed the medical device. A caregiver may include,for example, a medically trained professional, such as a physician,physician assistant, or nurse. In addition, a busy nurse or othercaregiver in a hospital may provide a medical device to a bedriddenpatient without providing the patient any guidance as to the appropriateways to interact with the medical device. These patients may,consequently, believe that they should not touch or interact with themedical device regardless of the alarms being issued or contact acaregiver should any issue arise with the device (or medical conditionof the patient). The lack of communication by the patient to thecaregiver regarding events experienced by the patient may cause longdelays between an event occurring (e.g., a patient experiences anarrhythmia) and the caregiver being notified.

The medical device as disclosed herein in some examples is capable ofproviding a first set of information directed to a caregiver of thepatient (e.g., via a caregiver interface) and a second set ofinformation directed to the patient (e.g., via a patient interface), orin some circumstances a guardian of the patient, such as a family memberwho is typically not medically trained. In a hospital setting, forexample, the medical device may communicate with a nurse through acaregiver interface to help the nurse setup, configure, and/or operatethe medical device for the patient. The information directed to thecaregiver may require entry of one or more security credentials (e.g.,username and password) to, for example, restrict the patient fromaccessing the caregiver interface. The medical device may also issuevarious alerts, alarms, and/or messages to the patient to instruct thepatient on device operation, how to delay the administration of therapythrough a patient interface should the patient be conscious, etc.

In some examples, the first and second sets of information directed tothe caregiver and/or the patient may include various training modules.These training modules may include, for example, training modules forthe caregiver to administer to the patient (e.g., training modules forthe caregiver to step through with the patient). For example, thetraining modules may include one or more modules to train the patient onthe sequence of events that may be encountered by the patient prior totreatment being applied. It is appreciated that the training modules maybe directed to the patient and/or the caregiver personally. For example,the training modules may include a showering training module to trainthe caregiver on the appropriate way to shower the patient with themedical device. In other implementations, the training modules can bedirected to other personnel (e.g., patient service representatives)involved in the deployment of the medical device.

The medical device may issue various reminders to the caregiver and/orthe patient to complete various training modules. For example, themedical device may remind the caregiver to administer training to thepatient upon initialization of the medical device and/or detection of anevent (e.g., connecting a battery to the medical device). The medicaldevice may provide reminders until the appropriate training has beencompleted.

In some examples, the medical device provides a notification for thepatient to contact a caregiver responsive to detecting an event. Forexample, the medical device may provide treatment to the patient andinstruct the patient to contact a caregiver. Other example events thatmay trigger a notification to the patient to contact a caregiver includedetecting a malfunction of the medical device, an error condition,detecting an arrhythmia, and delaying treatment of the arrhythmia. Thesenotifications to the patient remind the patient to contact a caregiverto make the healthcare provider aware of any changes in the medicalcondition of the patient and/or the condition of the medical device.

In various implementations described herein, the information directed toa user and/or audience can include notifications that are directedaccording to one or more roles of the user and/or the audience. Forexample, the information or notifications can be one or more directionsto a caregiver as described herein and as such include one or more ofaudio output, tactile output (e.g., vibration alerts or feedback),Braille output, and/or visual output such as text, graphics, video,animations and/or other information conveying features directed at thecaregiver. Similarly, information or notifications directed to a patientas described herein can include one or more of audio output, tactileoutput, Braille output, and/or visual output such as text, graphics,video, animations and/or other information conveying features directedat the patient. Information or notifications directed to a patientservice representative or a technical service person as described hereincan include one or more of audio output, tactile output, Braille output,and/or visual output such as text, graphics, video, animations and/orother information conveying features directed at the patient servicerepresentative or the technical service person. As described herein, theone or more notifications can further include user input features forreceiving a user's response to the one or more notifications. Forexample, a patient can respond to a voice or video notification byspeaking a command. For example, a patient may be able to respond to avisual notification by touching a user interface screen or pushing oneor more physical or user interface buttons.

Example Medical Devices

In some implementations, the medical device as described herein is anexternal or non-invasive medical device (e.g., in contrast to internalor invasive devices, such as implantable medical devices). For example,the external medical device can be a cardiac monitoring and/or automatedpacing device or defibrillator, such as an in-facility continuousmonitoring defibrillator (e.g., for patients that are confined to alimited space within a facility, such as, within a hospital environment,to a patient's room) or outpatient wearable defibrillators.

In some implementations, an external medical device can be an automatedcardiac monitor or defibrillator that can be used in certain specializedconditions and/or environments such as in combat zones or withinemergency vehicles. The medical device can be configured so that it canbe used immediately (or substantially immediately) in a life-savingemergency. For example, the external medical device can be an automatedexternal defibrillator (AED). Such AEDs are available from ZOLL® MedicalCorporation of Chelmsford, Mass.

In some implementations, the external medical device is an ambulatorydevice (e.g., a device that is capable of and designed for moving withthe patient as the patient goes about his or her daily routine). In someexamples, the external medical device can be configured as a wearabledefibrillator, such as the LifeVest® wearable defibrillator availablefrom ZOLL® Medical Corporation of Chelmsford, Mass.

The devices as described herein may be capable of continuously,substantially continuously, long-term and/or extended use or wear by, orattachment or connection to a patient.

For example, devices as described herein may be capable of being used orworn by, or attached or connected to a patient, without substantialinterruption for a predetermined period of time. In some examples, suchdevices may be capable of being used or worn by, or attached orconnected to a patient for example, up to hours or beyond (e.g., weeks,months, or even years).

In some implementations, such devices may be removed for a period oftime before use, wear, attachment, or connection to the patient isresumed, e.g., to change batteries, to change or wash the garment,and/or to take a shower, without departing from the scope of theexamples described herein.

The devices as described herein may be capable of continuously,substantially continuously, long-term and/or extended monitoring of apatient.

For example, devices as described herein may be capable of providingcardiac monitoring without substantial interruption for a predeterminedperiod of time. In some examples, such devices may be capable ofcontinuously or substantially continuously monitoring a patient forcardiac-related information (e.g., ECG information, including arrhythmiainformation, heart sounds, etc.) and/or non-cardiac information (e.g.,blood oxygen, the patient's temperature, glucose levels, and/or lungsounds), for example, up to hours or beyond (e.g., weeks, months, oreven years).

In some implementations, such devices may be powered down for a periodof time before monitoring is resumed, e.g., to change batteries, tochange or replace the garment, and/or to take a shower, withoutdeparting from the scope of the examples described herein.

In some instances, the devices may carry out its monitoring in periodicor aperiodic time intervals or times. For example, the monitoring duringintervals or times can be triggered by a user action or another event.For example, one or more durations between the periodic or aperiodicintervals or times can be user-configurable.

In various implementations, the devices may be operated on battery powerfor a duration of the device's use after which the batteries may bereplaced and/or recharged.

In some implementations, the medical device as described herein can be ahospital based medical device including, for example, a cardiacmonitoring device, a defibrillator and/or pacing device. For example,such a hospital based device can include a defibrillator and/or pacingdevice configured for continuous or substantially continuous use, wear,connection, attachment, or monitoring to/of a patient in a hospitalenvironment. The hospital based device can include a plurality oftherapy and sensing electrodes that are attached to the patient's skin.In some examples, the sensing and/or therapy electrodes are disposableadhesive electrodes. In some implementations, the electrodes are affixedto an electrode assembly (a patch), which can then be adhesivelyattached to the patient's skin. The sensing and/or therapy electrodescan be attached to the patient's skin at particular locations asprescribed by a trained professional.

In some implementations, the medical device as described herein can beconfigured to monitor a patient presenting with syncope (e.g., byanalyzing the patient's cardiac activity for aberrant patterns that canindicate abnormal physiological function). In some examples, aberrantpatterns may occur prior to, during, or after the onset of syncopesymptoms. For example, the short-term outpatient defibrillator caninclude a plurality of electrodes and/or an electrode assembly (patch)that can be adhesively attached to the patient's skin. The patient mayreplace the electrodes and/or patches as prescribed.

For example, the medical device can include a user interface componentfor interacting with the medical device. For example, the user interfacecomponent can include at least one caregiver interface and at least onepatient interface. The device can include one or more input mechanisms(e.g., buttons) that are available via the patient interface so that thepatient can interact with the device to respond to a treatment alert. Insome examples, the medical device issues a treatment alert beforeproviding a treatment shock, and if the patient does not respond to thetreatment alert (e.g., by holding down one or more response buttons),the device can deliver the treatment shock to restore normal heartrhythm.

Example Wearable Medical Device

FIG. 1 illustrates an example wearable medical device 100. The wearablemedical device 100 includes a plurality of sensing electrodes 112 thatcan be disposed at various positions about the patient's body. Thesensing electrodes 112 are electrically coupled to a medical devicecontroller 120 through a connection pod 130. In some implementations,some of the components of the wearable medical device 100 are affixed toa garment 110 that can be worn on the patient's torso. For example, asshown in FIG. 1, the controller 120 can be mounted on a belt worn by thepatient. The sensing electrodes 112 and connection pod 130 can beassembled or integrated into the garment 110 as shown. The sensingelectrodes 112 are configured to monitor the cardiac function of thepatient (e.g., by monitoring one or more cardiac signals of thepatient). While FIG. 1 shows four sensing electrodes 112, additionalsensing electrodes may be provided, and the plurality of sensingelectrodes 112 may be disposed at various locations about the patient'sbody.

The wearable medical device 100 can also optionally include a pluralityof therapy electrodes 114 that are electrically coupled to the medicaldevice controller 120 through the connection pod 130. The therapyelectrodes 114 are configured to deliver one or more therapeuticdefibrillating shocks, pacing pulses, and/or TENS pulses to the body ofthe patient if it is determined that such treatment is warranted. Theconnection pod 130 may include electronic circuitry and one or moresensors (e.g., a motion sensor, an accelerometer, etc.) that areconfigured to monitor patient activity. In some implementations, thewearable medical device 100 may be a monitoring only device that omitsthe therapy delivery capabilities and associated components (e.g., thetherapy electrodes 114). In some implementations, various treatmentcomponents may be packaged into various modules that can be attached orremoved from the wearable medical device 100 as needed.

As shown in FIG. 1, the wearable medical device 100 may include a userinterface pod 140 that is electrically coupled to, integrated in, and/orintegrated with, the user interface of the medical device controller120. The user interface pod 140 can be attached to the patient'sclothing or to the garment 110, for example, via a clip (not shown) thatis attached to a portion of the user interface pod 140. Alternatively,the user interface pod 140 may simply be held in a person's hand. Forexample, such a user interface pod 140 can be a smartwatch or asmartphone. In some examples, the user interface pod 140 may communicatewirelessly with the user interface of the medical device controller 120,for example, using a Bluetooth®, Wireless USB, ZigBee, WirelessEthernet, GSM, or other type of communication interface.

The controller 120 may include response buttons and a touch screen thatthe patient can interact with in order to communicate with the medicaldevice 100. The controller 120 also includes a speaker for communicatinginformation to the patient and/or a bystander. In some examples, whenthe controller 120 determines that the patient is experiencing cardiacarrhythmia, the speaker can issue an audible alarm to alert the patientand bystanders to the patient's medical condition. In some examples, thecontroller 120 can instruct the patient to press and hold one or both ofthe response buttons on the medical device controller 120 to indicatethat the patient is conscious, thereby instructing the medical devicecontroller 120 to withhold the delivery of one or more therapeuticdefibrillating shocks. If the patient does not respond to an instructionfrom the controller 120, the medical device 100 may determine that thepatient is unconscious and proceed with the treatment sequence,culminating in the delivery of one or more defibrillating shocks to thebody of the patient.

FIGS. 2A-2B show an example of the medical device controller 120. Thecontroller 120 may be powered by a rechargeable battery 212. Therechargeable battery 212 may be removable from a housing 206 of themedical device controller 120 to enable a patient and/or caregiver toswap a depleted (or near depleted) battery 212 for a charged battery.The controller 120 includes a user interface such as a touch screen 220that can provide information to the patient, caregiver, and/orbystanders. The patient and/or caregiver can interact with the touchscreen 220 to control the medical device 100. The controller 120 alsoincludes a speaker 204 for communicating information to the patient,caregiver, and/or the bystander. The controller 120 includes one or moreresponse buttons 210. In some examples, when the controller 120determines that the patient is experiencing cardiac arrhythmia, thespeaker 204 can issue an audible alarm to alert the patient andbystanders to the patient's medical condition. In some examples, thecontroller 120 can instruct the patient to press and hold one or both ofthe response buttons 210 to indicate that the patient is conscious,thereby instructing the medical device controller 120 to withhold thedelivery of therapeutic defibrillating shocks. If the patient does notrespond to an instruction from the controller 120, the medical device100 may determine that the patient is unconscious and proceed with thetreatment sequence, culminating in the delivery of one or moredefibrillating shocks to the body of the patient. The medical devicecontroller 120 may further include a port 202 to removably connectsensing devices (e.g., ECG sensing electrodes 112) and/or therapeuticdevices (e.g., therapy electrodes 114) to the medical device controller120.

FIG. 3 shows a schematic of an example of the medical device controller120 of FIGS. 1, 2A, and 2B. The controller 120 includes at least oneprocessor 318, a user interface manager 314, a sensor interface 312, anoptional therapy delivery interface 302, data storage 304 (which mayinclude patient data storage 316), an optional network interface 306, auser interface 308 (e.g., including the touch screen 220 shown in FIG.2), and a battery 310. The sensor interface 312 may be coupled to anyone or combination of sensors to receive information indicative ofcardiac activity. For example, the sensor interface 312 may be coupledto one or more sensing devices including, for example, sensingelectrodes 328 configured to sense an electrocardiogram (ECG) signal ofthe patient. The therapy delivery interface 302 (if included) may becoupled to one or more electrodes that provide therapy to the patientincluding, for example, one or more therapy electrodes 320, pacingelectrodes 322, and/or TENS electrodes 324. The sensor interface 312 andthe therapy delivery interface 302 may implement a variety of couplingand communication techniques for facilitating the exchange of databetween the sensors and/or therapy delivery devices and the controller120.

In some examples, the network interface 306 can facilitate thecommunication of information between the controller 120 and one or moreother devices or entities over a communications network. For example,the network interface 306 may be configured to communicate with a server(e.g., a remote server) where a caregiver can access information relatedto the patient. As discussed in more detail below with reference to FIG.4, the network interface 306 may facilitate communication between themedical device controller 120 and a base station associated (e.g.,paired) with the medical device controller.

In some examples, the medical device controller includes a cardiac eventdetector 326 to monitor the cardiac activity of the patient and identifycardiac events experienced by the patient based on received cardiacsignals. In some examples, the cardiac event detector 326 can accesspatient templates (e.g., which may be stored in the data storage 304 aspatient data 316) that can assist the cardiac event detector 326 inidentifying cardiac events experienced by the particular patient.

The at least one processor 318 can perform a series of instructions thatcontrol the operation of the other components of the controller 120. Insome examples, the user interface manager 314 is implemented as asoftware component that is stored in the data storage 304 and executedby the at least one processor 318 to control, for example, the userinterface component 308. The user interface manager 314 may controlvarious output components and/or devices of the medical devicecontroller 120 to communicate with external entities consist withvarious acts and/or display screens described herein. For example, suchoutput components and/or devices can include speakers, tactile and/orvibration output elements, visual indicators, monitors, displays, LCDscreens, LEDs, Braille output elements, and the like.

In some implementations, the user interface component 308 can includeone or more interfaces for communicating and/or interacting withdifferent external entities. For example, such interfaces can include acaregiver interface for communicating and/or interacting with acaregiver (e.g., a nurse, a physician, a physician's aide or assistant,or other such individual or entity), a patient interface for a patient(or a layperson guardian of the patient), a patient servicerepresentative interface for a patient service representative, or aservice interface for a service technician, among others. For example,the one or more interfaces can be displayed on a same physical displayand/or touchscreen. In some cases, the external entities may be assignedseparate security credentials that may be provided before access isgranted to the corresponding interface. In some examples, the one ormore interfaces can be displayed on different physical displays and/ortouchscreens. For example, a caregiver interface may be displayed on afirst display, and a patient interface may be displayed on a second,different display.

For example, the user interface manager 314 may cause the user interfacecomponent 308 to switch from a first one of the one or more interfacesto a second one of the one or more interfaces depending on a currentdevice function or operation. As an example, the user interfacecomponent 308 may display “Call Caregiver” to the patient via a patientinterface when a device related event is detected as described infurther detail below. When the caregiver arrives, he or she may providehis or her security credentials and access a caregiver interface foraddressing the device related event.

Example Monitoring Medical Device

In some examples, the medical device may be a patient monitoring device.For example, such a patient monitoring device may be configured tomonitor one or more of a patient's physiological parameters without anaccompanying treatment component. For example, a patient monitor mayinclude a cardiac monitor for monitoring a patient's cardiacinformation. Such cardiac information can include, without limitation,heart rate, ECG data, heart sounds data from an acoustic sensor, andother cardiac data. In addition to cardiac monitoring, the patientmonitor may perform monitoring of other relevant patient parameters,including glucose levels, blood oxygen levels, lung fluids, lung sounds,and blood pressure.

An example cardiac monitoring medical device (e.g., a cardiac monitor)may be similar to wearable medical device 100 described with referenceto FIGS. 1-3 and omit, for example, the therapy electrodes 114 and/orthe therapy delivery interface 302. In some implementations, the cardiacmonitor is capable of and designed for being worn by a patient who is atrisk of developing cardiac problems, but who does not yet meet criteriato be outfitted with a medical device that includes a treatmentcomponent (e.g., a defibrillator). Thus, the cardiac monitor may beprescribed so that continuous and/or event-based data can be sent fromthe cardiac monitor to a remote server. A caregiver can access the datafrom the remote server and determine whether the patient is experiencingor has experienced a cardiac problem. In some implementations, afterdetermining that the patient is experiencing a cardiac problem, thecaregiver may instruct the patient to begin wearing a medical devicewith treatment capabilities.

In some implementations, the patient can interact with the userinterface 308 to identify a patient symptom. The user interface 308 mayinclude a drop down menu or check list that allows the patient to selecta particular symptom from a list of alternatives. Options for patientsystems can include one or more of: feeling a skipped beat, shortness ofbreath, light headedness, racing heart rate, fatigue, fainting, chestdiscomfort, weakness, dizziness, and/or giddiness. In addition, thepatient can select a level of activity (e.g., light activity, moderateactivity, rigorous activity, etc.) that he or she was performing whenthe symptom occurred. In some implementations, in response to theselection by the patient, the cardiac event detector 326 can cause aportion of patient physiological information (e.g., in the form of acardiac signal) to be captured for a length of time that is based onwhen the symptom was experienced. For example, the cardiac eventdetector 326 can cause a portion of an ECG signal of the patient to becaptured. The portion of the ECG signal is sometimes referred to hereinas an ECG strip. In some implementations, the cardiac monitor cancontinuously record ECG data, and at the same time also identify andrecord one or more ECG strips relating to one or more events of interest(e.g., patient-reported symptoms, events detected by the cardiac eventdetector 326, etc.). As such, if a caregiver wishes to view ECG data fora period of time prior to or after the recorded ECG strip relating to anevent of interest, such data is available for review from thecontinuously-recorded ECG data.

Example Base Station

In some examples, the medical device controller may be in communicationwith a base station capable of performing a number of differentfunctions. FIG. 4 illustrates an example medical device controller 120in communication with a base station 400. As illustrated, base station400 includes an antenna 402, a battery charging bay 404, one or morebuttons 406, a speaker 408, a display 410, and one or more communicationinterfaces 412, 414, and 416. It is appreciated that the base station400, in some examples, may omit one or more of the elements depicted inFIG. 4.

The base station 400 communicates with the medical device controllervia, for example, wired or wireless communication link 418. With respectto wireless communication, such a link 418 may be implemented throughany one or combination of wireless communication standards and protocolsincluding, for example, BLUETOOTH, Wireless USB, ZigBee, and WirelessEthernet. In some examples, the medical device controller 120 may bepaired to (e.g., connected to) a particular base station 400 through oneor more procedures as described further below. The medical devicecontroller 120 may provide, for example, information regarding thepatient's medical condition and/or the status of the medical device tothe base station 400.

The information received by the base station 400 may be communicatedover a wired or wireless network shortly after it is received by thebase station 400, or alternatively, may be stored in a memory of thebase station 400 and communicated over the network at a later time. Forexample, the network can be a telephone or cellular service network(e.g., Global System for Mobile Communications (GSM), High Speed PacketAccess, mobile network standards known as 3G, 4G, Long Term Evolution(LTE), or LTE Advanced, or the like. For example, the network can be awired computer network that connects the base station 400 to a localarea network (LAN), wide area network (WAN), the Internet, or the like.To facilitate wired network connections, the base station 400 caninclude one or more ports (e.g., RJ-45, or telephone cable ports) asfurther described below. The information that is communicated by thebase station 400 may be retained in the memory of the base station 400.

Another of the functions performed by the base station 400 is to storeand/or communicate information received from the medical devicecontroller 120 over the wired or wireless communication network. Forexample, information relating to the device and/or patient's medicalcondition over a period of time may be communicated periodically oraperiodically by the base station 400 to a remote location. For example,the remote location can include equipment for securely receiving suchmedical data over the network. For example, the remote location may be atechnical service center for receiving and processing the informationfrom the base station 400. In some examples, the information may becomplied into a report and provided to a medical care provider, e.g.,the patient's doctor in a report. Such reports may be configured to beprovided periodically, such as daily, weekly, or monthly, or in responseto a user, device, or doctor triggered event.

For example, the remote location may be a medical service provider, suchas a doctor, so that the doctor may remotely monitor the patient'smedical condition. The base station 400 also includes several differentcommunication interfaces including: a device communication interface 412to receive information from the controller 120 of the medical devicecontroller 120, a telephone network interface 414 to communicate, via atelephone network, the information received from the medical devicecontroller 120, and a network interface 416 to communicate, via a wirednetwork connection, the information received from the medical devicecontroller 120. In certain embodiments, the base station 400 alsoincludes an antenna 402 that can wirelessly communicate the informationreceived from the medical device controller 120 via a cellular (e.g.,2G, 3G, and 4G) network.

In some examples, the base station 400 is capable of charging arechargeable battery for the medical device controller 120. In theseexamples, the base station 400 may include a battery charging bay 404constructed to receive and charge a battery for the medical devicecontroller (e.g., battery 212). The medical device may be provided withmultiple batteries to enable a patient and/or caregiver to charge onebattery while another charged battery is used to provide power to themedical device. The batteries may be swapped between the medical devicecontroller 120 and the base station 400 once the battery in the medicaldevice controller is depleted (or near depleted). It is appreciated thatthe base station 400 may include any number of battery charging bays 404to, for example, charge multiple batteries for the medical devicecontroller 120 simultaneously.

Example Medical Device for Use in a Health Care Facility Setting

As discussed above, the medical device controller 120 may be well-suitedfor a range of different cardiac monitoring and/or treatment devices. Insome examples, the medical device controller 120 is part of a medicaldevice for use in an inpatient context, e.g., for use with patientsadmitted to a health care facility, such as, a hospital. In an example,when a patient is admitted to a health care facility, such as ahospital, medical devices as described herein can be configured forcontinuous, substantially continuous, long-term and/or extended use orwear by, or attachment or connection, to the patient. For example, thepatient can be cared for in the health care facility for a periodranging from a few minutes or hours of observation and/or treatment, todays, weeks, or even months. In operation, such a hospital based medicaldevice may operate in a manner such that an interface, prompts, andcommunication performed by the hospital based medical device can beconfigured for and/or directed to a user other than the patient 102,e.g., a caregiver such as a nurse or a patient service representative inthe health care facility. For example, a caregiver can program thedevice and/or set the medical device up for use by the patient 102admitted to the health care facility. The interface, prompts, andcommunication can be directed to the patient 102 in scenarios such aswhen a response is required to let the device know whether or not thepatient 102 is conscious, which can be used in deciding when to shockthe patient 102, and when a patient is given an alert to call thecaregiver (e.g., “Call Caregiver” as described in further detail below).

FIG. 5 illustrates an example hospital based medical device employingthe medical device controller 120. The hospital based medical device maybe constructed to provide cardiac monitoring and/or treatment forpatients in a hospital setting who may be, for example, bedridden and/orlimited-mobility patients. For example, such patients' movement may belimited to a room within or a portion of the health care facility for atleast a substantial portion of the time that the patient is admitted tothe health care facility. Providing such patients in with the hospitalbased medical device may, in some cases, advantageously reduce the timebetween the patient experiencing a cardiac event and the notification ofhospital staff, the administration of life-saving defibrillation pulses,and/or the administration of pacing pulses. For example, hospitalpatients who may experience a cardiac event might have to wait for aphysician to go to the patient's room, assess the condition of thepatient, locate a defibrillation device, attach the defibrillationdevice to the patient, and provide treatment to the patient. Thehospital based medical device as described herein can providecontinuous, substantially continuous, long-term and/or extendedmonitoring of a patient for cardiac arrhythmias or other physiologicalconditions and, in response to detecting a treatable condition, providea treatment to the patient (e.g., one or more pulses or shocks toconvert a cardiac arrhythmia). For example, reducing the time betweenthe patient experiencing a life-threatening cardiac event and providinglife-saving defibrillation or pacing pulses can improve the likelihoodof the patient surviving the cardiac event.

As illustrated in FIG. 5, the hospital based medical device 500 includesthe medical device controller 120 and a sensing component 502. Thesensing component 502 includes a connector 510 constructed to removablycouple to the port 202 of the medical device controller 120. The sensingcomponent 502 may detect information indicative of cardiac activity ofthe patient including, for example, ECG activity, tissue fluid, lungfluid, lung sounds, heart sounds, and/or patient activity. In someexamples, the sensing component 502 includes one or more electrodes 506.The electrodes 506 may be stick-on adhesive electrodes constructed toattach to the patient. In some examples, the electrodes 506 may bedetachable from a wire lead coupling the electrode 506 to the connector510. Constructing the sensing component 502 to make the electrodes 506detachable may enable the patient and/or caregiver to periodically(e.g., every 24-48 hours or more, as prescribed) replace the electrodes506 without replacing the entire sensing component 502. For example, theelectrodes 506 may be long term wear electrodes that are configured tobe continuously worn by a patient for extended periods (e.g., 3 or moredays). One example of such an electrode is described in U.S. PatentApplication Publication No. US2013/0325096, titled “LONG TERM WEARMULTIFUNCTION BIOMEDICAL ELECTRODE,” (hereinafter the “'096publication”) published Dec. 5, 2013 and issued as U.S. Pat. No.9,737,701.

In some examples, the hospital based medical device 500 may also includea treatment component 504 to provide treatment to the patient. Thetreatment component 504 may include, for example, a therapy pad 508configured to attach to the patient. The treatment component 504 may beconnected to the same connector 510 as the sensing component 502 and/oremploy a separate connector that is capable of coupling to the connector510 in a modular fashion. It is appreciated that the treatment component504 may be integrated into the sensing component 502 in a combinedsensing-treatment component. The combined sensing-treatment componentmay include an electrode with integrated sensing and treatment deliverycapabilities as described in the '096 publication. Although one therapypad 508 is depicted for illustration purposes, it should be appreciatedthat more than one therapy pad 508 may be provided.

In some examples, the controller 120 of the hospital based medicaldevice 500 is communicatively coupled to a base station such as basestation 400 described above. The hospital based medical device 500 maycommunicate, for example, patient information and/or status informationof the medical device to the base station 400. In these examples, thebase station 400 may issue alerts to medical personnel (e.g., at thehospital) and/or provide the information to a remote server that isaccessible by medical personnel.

New Patient Setup

In some examples, a caregiver (e.g., a nurse, a physician's aide orassistant, or a physician) may configure the medical device for thepatient in the health care facility prior to deploying the device on thepatient. For example, the caregiver may access the setup screen via acaregiver interface to initiate a device-guided patient setup process.In the following description, although the user interacting with themedical device is described as being a caregiver, it is appreciated thatthe user can be any authorized person involved in the care or treatmentof the patient or the deployment of the medical device, e.g., a patientservice representative). For example, a patient service representativemay access the device-guided patient setup via a separate patientservice representative interface. For example, the caregiver may inputpatient information into the medical device in order to adapt the deviceto the patient. FIGS. 6A and 6B illustrate an example set of userinterface screens displayed to the caregiver via, for example, touchscreen 220 on the medical device controller 120 to setup the medicaldevice. It is further appreciated that the screens and screen sequencesdescribed below are for illustration only and should not be construed asbeing the only way to implement the concepts described herein. Forexample, in the context of new patient setup, the sequence of caregiverscreens or the screens themselves can be changed from those shown inFIG. 6A or 6B to include other screen sequences or screens related todevice and/or patient setup without departing from the spirit of theconcepts described herein.

For example, the medical device controller 120 may be configured todisplay the set of user interface screens to the caregiver illustratedin FIGS. 6A and 6B responsive to the device either being manually placedin (e.g., through a user providing input) or automatically entering anew patient mode. The new patient mode may be invoked by, for example,fitting the medical device to a new patient. The medical device maydetect that a new patient is being fitted by, for example, monitoring astatus of the port 202 of the medical device controller 120. Forexample, the medical device may enter the new patient mode responsive toone or more devices (e.g., cardiac sensing component 502) beingdisconnected from the port 202, one or more devices being connected tothe port 202, and/or a battery being connected to the medical device. Insome examples, the device may, through the sensing component 502, detectthat the patient's ECG profile is significantly different from one ormore baseline ECG profiles stored in the device's memory. In such cases,the device can automatically enter the new patient mode.

In some examples, where a same patient that was previously using thedevice is being reconnected to the device, the caregiver can cause thedevice to exit the new patient mode and continue using the patient'spreviously entered information. In some examples, the caregiver may beprompted to review the patient's information and confirm the same.

As shown in screen 602, the medical device controller may display acaregiver menu button 616 that allows a caregiver to access thecaregiver interface. For example, the medical device controller mayproceed to screen 604 upon detection of the menu button 616 beingactivated (e.g., tapped by a caregiver). In screen 604, the medicaldevice controller requests a caregiver password to be entered into thepassword field 620 via a keypad 618 prior to granting access to thecaregiver interface. The medical device controller may request securitycredentials to limit access to the new patient setup to certainindividuals involved in providing care to the patient. For example, themedical device controller may restrict access to the new patient setupto a caregiver (e.g., a nurse) who has been previously authorized accessto the caregiver interface. In some examples, the device can beconfigured to provide different access levels to personnel involved inthe patient's care along with corresponding different sets of securitycredentials. For example, a physician, physician's aide or assistant,nurse, a designee, or other authorized person may have separate sets ofcredentials, and their corresponding profiles and access levels mayallow them to modify the device's settings with respect to the patienttreatment protocol (e.g., rate thresholds and/or energy levels of eachtreatment shock). In one implementation, the device can be set up suchthat only a user with physician level access can modify the patienttreatment protocol. In another implementation, the device may be set upto allow a user with caregiver level access, e.g., any of a physician,physician's aide or assistant, nurse, a designee, or other authorizedperson, to modify the patient treatment protocol. Hospitaladministrative personnel, on the other hand, may be limited to enteringthe patient information (e.g., patient's name, age, and suchinformation) and may not be able to modify the treatment parameterswithout prior explicit authorization. In various implementations, anauthorized technical service representative may be able to accessadditional device settings not available to any of the other users ofthe device. In some examples, the patient may be permitted to access(e.g., with or without security credentials) a limited set of optionsvia the user interface.

If the medical device controller determines that the password enteredvia the keypad matches the password for the device (e.g., a passwordstored in the memory or at a remote database securely accessible by thedevice), the medical device controller proceeds to screen 606 of thecaregiver interface.

In screen 606 of the caregiver interface, the medical device controllerdisplays a caregiver menu including one or more options. As noted,depending on the user profile (physician or patient servicerepresentative), the menu may provide different options corresponding tothe allowed interactions permitted for the user. In this case, forexample, the caregiver options may include, for example, a new patientoption as illustrated by the new patient button 622. The medical devicecontroller proceeds to screen 608 responsive to the new patient button622 being activated where a warning is presented to the caregiver thatcan be acknowledged by the acknowledge button 624. In screen 610 thepatient's name may be entered in the patient name field 626 via thekeypad 618. In screen 612, heart rate thresholds for ventriculartachycardia (VT) and ventricular fibrillation (VF) may be received fromthe caregiver. The medical device controller proceeds to screen 614illustrated in FIG. 6B once the VT and VF thresholds are received fromthe caregiver.

In screen 614, the medical device controller receives a center codeassociated with the facility where the medical device is deployed in thecenter code field 628 via the keypad 618. The medical device controllerreceives information regarding the current time zone in screen 615 anddisplays the settings received from the caregiver in screen 617 that canbe acknowledged by the acknowledge button 630.

Configuration of the Medical Device

The medical device controller, in some implementations, may allow acaregiver to configure the medical device controller after the initialsetup described above with respect to FIGS. 6A and 6B. For example, themedical device controller may allow a caregiver to pair the medicaldevice controller with a particular base station.

As noted, in a busy hospital environment, there may be a plurality ofbase stations within vicinity of the medical device controller. As such,it may be necessary for the controller to be configured to be pairedwith a particular base station to be associated with the patient usingthe medical device. When a patient is discharged and the devicereconfigured to be used with a new patient, it may be necessary tore-pair the device with a same or a different base station depending onwhich base station is being used for the new patient. Moreover, acaregiver may wish to check in on the patient to view a status of thedevice to ensure that the device is operating well and that noexceptions have been reported. A caregiver may wish, for example, tocheck on a status of the electrodes, confirm that the ECG data is beingcorrectly received, monitored, and stored, or, in the event of a patientsymptom, record an ECG strip for subsequent analysis.

Various status parameters of the medical device controller may also bemade accessible to the caregiver to enable the caregiver to, forexample, troubleshoot the medical device and/or assess a medicalcondition of the patient. FIGS. 7A-7D illustrate an example set ofcaregiver interface screens displayed by the medical device controllerto enable a caregiver to pair the medical device with a base station(FIG. 7A), monitor the electrode status (FIG. 7B), see live ECG data(FIG. 7C), and record the heart rhythm of the patient (FIG. 7D).

Referring to FIG. 7A, a home screen is displayed to the caregiver inscreen 702 including, for example, the heart rate of the patient 714,the name of the patient 716, and a caregiver menu button 616. Asdescribed above with respect to FIG. 6A, the medical device controllermay present the caregiver menu screen 706 of the caregiver interfaceafter receiving the correct caregiver password in screen 704. Thecaregiver menu screen 706 includes one or more options including a paircharger button 718, an electrode status button 720, a live ECG databutton 722, and a record heart rhythm button 724. The medical devicecontroller proceeds to screen 708 responsive to activation of the paircharger button 718 in screen 706 and displays a warning that may beacknowledged by the acknowledge button 728. The medical devicecontroller proceeds to screen 710 and displays the nearby base stationsthat may be selected by the caregiver. If no base stations are detected,the medical device controller displays screen 712 informing thecaregiver that no base stations were detected.

FIG. 7B illustrates the same first three screens 702, 704, and 706 asdescribed above. The medical device proceeds to screen 730 responsive tothe electrode status button 720 being activated in screen 706illustrating the status of the one or more electrodes (e.g., sensing ortreatment) attached to the patient. The screen 730 may show a checkmarkon electrodes that are properly attached to the patient and an “X” markon electrodes that are improperly attached to the patient to indicate tothe caregiver which electrodes need attention. The medical device mayalso display the live ECG data button 722 in screen 730 to enable acaregiver to cause the medical device to transition to screen 732showing live ECG data of the patient. FIG. 7C illustrates a similar setof screens 702, 704, 706, 730, and 732 in a different sequence caused byactivation of the live ECG data button 722 in screen 706 (as opposed tothe electrode status button 720).

FIG. 7D illustrates the same first three screens 702, 704, and 706 asdescribed above. The medical device proceeds to screen 734 responsive tothe record heart rhythm button 724 being activated. Screen 734 adds arecording in progress indicator 736 to the home screen 702. Therecording in progress indicator 736 provides a notification to thecaregiver that the ECG signal of the patient is being recorded by themedical device. The medical device may also transmit the recorded ECGdata to a remove server (e.g., via a base station) for later access byvarious medical personnel.

It is appreciated that other mechanisms apart from the password andkeypad illustrated in screens 604 and 704 may be employed as securitycredentials by the medical device to limit access to one or more screensin the caregiver interface. For example, the medical device may employ aunique series of interactions with the medical device. As illustrated inFIG. 8A, the caregiver menu screen 706 may be accessible after themedical device receives a unique set of pushes (e.g., three pushes insequence) of the response button 210. In some examples, the uniquesequence of events may be employed to invoke one or more specificactions to be performed by the medical device and, thereby, bypass thecaregiver menu illustrated in screens 606 and/or 706. For example, asillustrated in FIG. 8B, the medical device may automatically beginrecording the ECG signal of the patient and transition to screen 734responsive to detecting a unique series of pushes of the response button210.

It is appreciated that yet other mechanisms may be employed to limitaccess to various screens of the user interface. For example, themedical device may include voice recognition capability and the medicaldevice may display the caregiver menu in screen 606 responsive toreceiving a voice command from a caregiver that matches a stored voicesignature.

Training the Patient

The medical device may provide the caregiver access to one or moretraining modules for the caregiver to administer to the patient. Thepatient may be unfamiliar with the medical device and/or incorrectlyassume that he or she should not touch or interact with the medicaldevice regardless of the circumstances. These training modules may beadministered the patient to familiarize the patient with the medicaldevice. FIGS. 9A-9C illustrate an example set of caregiver interfacescreens for the caregiver to administer training to the patient. It isappreciated that the screens illustrated in FIGS. 9A-9C may be precededby one or more screens requiring security credentials of the caregiverincluding, for example, screens 702 and 704 illustrated above in FIGS.7A-7D.

Referring to screen 902 in FIG. 9A, an example caregiver menu is shownincluding a training button 914 that causes the medical device totransition to screen 904 responsive to being activated. The screen 904provides a reminder to the caregiver to demonstrate the treatmentsequence to the patient and/or remind the caregiver to reassure thepatient that no defibrillation pulse will be provided to the patientduring the training. The medical device may transition to screen 906once the acknowledge button has been activated. Screen 906 illustrates atraining screen with various training modules to select including, forexample, a treatment sequence demonstration module (activated by button918) and an alarm demonstration module (activated by button 920). Themedical device transitions to screen 908 responsive to the treatmentsequence button 918 being activated. Screen 908 provides a notificationto the patient to respond by pushing the response button and/or informsbystanders not to interfere with the treatment sequence. The medicaldevice transitions to screen 910 responsive to the response button 210being pushed. Screen 910 indicates that the treatment is being delayedand alternates with screen 912 informing the patient to call the nurseor other caregiver.

The medical device transitions to caregiver interface screen 922 in FIG.9B once the response button 210 has been released where a notificationthat the treatment is being delayed is displayed in combination with atimer counting down until treatment is provided to the patient. Thescreen 922 alternates with the call caregiver screen 924 that may alsoinclude the timer counting down until the administration of treatment.The medical device transitions to screen 926 once the timer has expiredwithout administering therapy (because the medical device is in atraining mode) notifying the patient that treatment has beenadministered. The screen 926 may alternate with the screen 912 notifyingthe patient to call the nurse or other caregiver. Were the medicaldevice not in a training mode, treatment would be provided to thepatient and the medical device may alternate between display screen 926and 912 as shown.

In FIG. 9C, the first three screens 902, 904, and 906 may be similar tothe screens described above with the same reference numbers. FIG. 9Cillustrates that sequence of screens when the alarm demonstration button920 is activated (as opposed to the treatment sequence button 918). Themedical device transitions to screen 928 responsive to the alarmdemonstration button 920 being activated that displays one or morebuttons that play an associated alert capable of being provided by themedical device. For example, the medical device may employ two types ofaudible alerts and the screen 928 may include a first button that causesthe medical device to issue the first type of audible alert and a secondbutton that causes the medical device to issue the second type ofaudible alert.

Nurses and other caregivers in a busy hospital environment may outfitpatients with a medical device without giving the patients adequatetraining. For example, a patient may not be trained on how toappropriately respond to certain device alerts and/or do things that arerequired of them in the event of the alert. FIG. 10 illustrates anexample process 1000 to remind the caregiver to provide training to thepatient.

In act 1002, the medical device determines that the device has beeninitialized. In some implementations, the medical device may determinethat the device has been initialized by detecting, for example, theconnector 510 being plugged into the port 202 of the controller 120, theinitiation of communication between one or more sensing devices (e.g.,sensing component 502) and the controller 120, a battery 212 beinginserted into and/or connected to the controller 120, a predeterminedperiod of time elapsing, and/or the medical device being fitted to thepatient. The medical device may also determine that the device has beeninitialized by detecting that the setup screens for the medical device(e.g., screens 602-617 in FIGS. 6A and 6B) have been accessed by thecaregiver.

In act 1004, the medical device determines whether user training wascompletely administered. For example, the device can be configured torequire that one or more patient training modules be completed (e.g., bythe caregiver administering the training to the patient) prior todeployment of the medical device on the patient. In some cases, thedevice can be configured to require that one or more caregiver trainingmodules also be completed prior to deployment of the medical device.

For instance, in the event of a software update or a new featurerelease, it may be desirable that the caregiver be trained on the newdevice update or feature. As an example, after the device update orfeature is installed, the device can issue a notification relating tothe training on the update or feature. In some examples, a user of thedevice can be monitored for, e.g., abuse and/or compliance with deviceuse guidelines. For instance, if a device abuse event is detected (e.g.,the device perceives an impact exceeding a threshold), the device canissue a notification relating to a training module on device use and/orcare. For instance, if the device detects that a device is beingmisused, e.g., a connector from the electrodes to the device is beingimproperly inserted, the device can automatically issue a notificationrelating to a training module on correct device use, e.g., in this case,correct inserting of the connector to the device.

Other device use events that can trigger training notifications asdescribed herein include, for example, disconnecting the electrodeconnector when the device is active and/or prior to the device beingturned off, improper battery insertion attempt(s), improper batterychange event(s), incorrect sensing electrode(s) placement on the body ofthe patient, incorrect treatment electrode(s) placement on the body ofthe patient, incorrect treatment parameters being entered for thepatient, and improper or incorrect user input.

For example, an improper battery change event can include determiningthat the device battery is approaching a predetermined amount ofremaining battery charge (e.g., 15% or other preconfigured default oruser configured level of charge). For example, incorrect sensingelectrode placement can be automatically sensed by detecting whether anappropriate ECG signal of the patient is being detected. For example,incorrect treatment electrode placement can be automatically sensed bydetecting a test signal (e.g., an electrode falloff signal) that is sentthrough the patient's body is received at a receiver configured todetect for such a signal. For example, such a test signal can beconfigured to have a predetermined frequency (e.g., in MHz range) suchthat the receiver can detect the signal.

For example, the incorrect treatment parameters or improper user inputevent can be in the form of one or more values being entered into thedevice setup screen corresponding to the patient treatment protocol thatare incorrect. For instance, if a physician or other caregiver attemptsto enter a shock energy value for a treatment pulse that violates anestablished rule (e.g., the value is lower than a shock energy valueassigned to a previous treatment pulse), the device can issue a trainingnotification or alert prompting that the caregiver complete a treatmentprotocol training session to ensure that correct shock energy values arebeing entered for the patient. Other improper and/or incorrect userinput events can include pressing the response button(s) when there isno need for any response button actuation, pressing one or more userinterface buttons at inappropriate times, and/or attempting to causedata transfer to the base station during an inappropriate time (e.g.,when the device does not need to send any data to the base station).

For example, the device may cause the notification to be issued ondetecting a number of such device abuse and/or improper use events inexcess of a predetermined threshold. For instance, in the case ofimproper electrode placement, if an incorrect or improper ECG signal isreceived after three electrode placement attempts, the device canautomatically issue the training notification. Similarly, if the devicemay not issue the training notification relating to a battery changeevent until it has detected three or more such infractions. Forinstance, the threshold number of events that initiate the trainingnotification can be a preconfigured default value or user configurableby a user with the appropriate authorization and access level.

In some examples, the training notification may be in the form of ananimation graphically displaying proper electrode placement on the bodyof the patient. Such an animation may continue to play in a loop untileither a correct ECG signal is detected and/or the caregiver initiatesthe appropriate training module. In some examples, the trainingnotification screen may not be dismissed or closed without completingthe training module as described below. In some examples, the caregivermay temporarily suppress the notification for a period time (e.g., 10minutes or other preconfigured default or user-defined amount of time)until such time the caregiver completes the training module. In someexamples, the caregiver may be required to enter security credentials totemporarily suppress the notification. In some cases, the caregiver mayonly be able to temporarily suppress the notification without providingsecurity credentials, but may be able to provide his or her securitycredentials and turn off all future notifications regarding the trainingmodule.

If the device does not detect completion of the one or more requiredtraining modules as noted below, the device can be configured to issue anotification to the caregiver. For example, the notification can be inthe form of a “training required” or “training reminder” screen. Forexample, device can cause the notification screen can be configured toreceive user input (e.g., via a user interface button on the screen)and, responsive to the input, cause the corresponding training module tobe initiated.

In some implementations, the medical device can track progress throughthe training modules for detecting completion in the following manner.The medical device may, for example, track the screens displayed and/orthe training modules accessed by the caregiver. The medical device maydetermine that the caregiver has completed patient training responsiveto, for example, the number of completed training modules and/ordisplayed training screens transgressing a minimum threshold. It isappreciated that the duration of access to each of the training modulesand/or screens may be monitored to reduce the risk of a caregiverattempting to rush through the training. For example, each module mayhave an associated minimum duration of access that may be dependent uponthe length of the training module. For example, in a training modulerelating to device case, the device can be configured to ensure that thepatient reviews each screen for at least 10 seconds (or otherpreconfigured default or user-defined amount of time) before proceedingto a next screen. The medical device may determine that a trainingmodule has been completed responsive to the medical device displayingthe training module for at least the specified minimum amount of time.In another example, the medical device may monitor the number of screensand/or training module sections within a training module have beenviewed and indicate that the training module is complete responsive tothe number of screens accessed in the training module transgresses aminimum threshold.

For example, the device may be configured to determine that the trainingmodule is complete if at least 80% of screens within a training modulehave been reviewed. In another example, the device may be configured todeem the training module complete only if 100% of the screens have beenreviewed. For instance, a particular training module, such as, how topress the response buttons in response to an alert condition may beviewed as an important training module and as such for this particularmodule, the device can be configured to require that all screens of themodule are reviewed.

In some examples, the training module can include a quiz or an examplesimulation of a device alarm condition to confirm the user's (e.g., inthis case, the patient's) understanding of device features. Forinstance, the device can prompt the patient to respond to a simulatedcondition involving an alarm scenario to test the patient'sunderstanding of the device response mechanism.

In some implementations, the device can be configured to require userinput to progress from one screen to the next within a training moduleto confirm that a screen has been reviewed prior to displaying a nextscreen. In some implementations, if no user input is received within apredetermined amount of time, e.g., 2 minutes, the device may deem thetraining module as being aborted and exit the module. In some cases, thetraining module can be reset to an initial screen of the training modulein the absence of user input for the predetermined amount of time.

In various implementations, one or more of the thresholds or parametersdescribed above can be set to default values, and be modified by a userwith an appropriate access level and security credentials as describedabove.

If the medical device controller determines that the patient traininghas not been completed, the medical device may proceed to act 1006 andprovide a notification to the caregiver as illustrated by patienttraining notification 1008. The patient training notification 1008 mayremind the caregiver of the important of administering the trainingmodules to the patient prior to use of the device by the patient. Thepatient training notification 1008 may include an acknowledge button (asillustrated) for the caregiver to temporarily silence the notification.In some examples, the patient training notification 1008 may include anindication of a suggested training to complete. For example, the medicaldevice may determine that the patient treatment sequence training modulewas not completed and indicate in the patient training notification 1008that the patient treatment sequence training module needs to becompleted. The medical device may periodically repeat act 1004 andaccess whether the training has been administered to the patient andrepeat act 1006 of providing the notification 1008 until the caregiverappropriately administers the training modules to the patient. In someimplementations, the patient training notification 1008 may include an“Access training” button to allow the user to access the requiredtraining directly from the notification screen.

In some examples, the medical device may transmit a message to anexternal entity (e.g., via a base station) responsive to thenotification 1008 being displayed in act 1006 and/or the medical devicedetecting that one or more training modules were rushed in act 1004. Forexample, the medical device may send a message to a supervisor of thecaregiver indicating that the caregiver has inappropriately attemptedpatient training and/or has repeatedly failed to train the patient onthe medical device. For example, the medical device may maintain a logof such information for later review.

It is appreciated that other training modules may be included in themedical device controller that may be directed to the caregiver,patient, and/or bystander personally. For example, the medical devicemay include a hospital based medical device and include a showeringtraining module to train the caregiver on the appropriate procedure toshower the patient with the medical device. The showering trainingmodule may indicate, for example, that the medical device should beremoved from the patient prior to showering. The medical devicecontroller may further include a medical device care training module totrain the caregiver and/or the patient on the appropriate procedure tocare for the medical device while it is in use. For example, the medicaldevice care training module may indicate that the batteries and/or theelectrodes need to be changed periodically. These training modules maybe made available to the caregiver in hospital based medical devicesvia, for example, the training menu screen 906. Other example trainingmodules include, for example, a response button training module, agarment training module, a device action training module, a pacingtraining module, a defibrillation training module, and/or an arrhythmiadetection training module.

The medical device may issue one or more notifications to remind theappropriate individual (e.g., the patient, the caregiver, and/or abystander) of the appropriate procedures to interact with the medicaldevice. The notifications may be triggered by various events. Forexample, the medical device may detect that a predetermined amount oftime has passed since the last time a particular training module wasreviewed. In some examples, the medical device may issue a targetedtraining notification responsive to detecting misuse of the medicaldevice. For example, the medical device may detect that one or moreelectrodes are improperly attached to the patient and provide anotification to review a training module regarding electrode attachment.In another example, the medical device may detect that the batterycharge level is below a threshold and provide a notification to review abattery care training module and/or a notification that the batterycharge level is low.

Medical Device Alerts

Patients in an in-hospital setting may not immediately call a caregiverwhen the medical device issues an alert or alarm stating, for example,that an arrhythmia has been detected and/or that therapeutic shocks havebeen provided to the patient. The patients may, for example, only pushthe response buttons in response to an arrhythmia notification. In suchsituations, the hospital staff may not find out about the arrhythmiaevent until several minutes, maybe even hours after the event hasoccurred. Accordingly, in some examples, the medical device provides anotification for the patient to call a caregiver in response to thedetection of various events (e.g., an arrhythmia). In someimplementations, the device can be configured to automatically transmita notification to an appropriate caregiver station tasked withmonitoring the patient's condition.

FIGS. 11A-11C illustrate example screens displayed by the medical devicein response to various events alerting the patient to call a nurse orother caregiver and indicating, to the nurse or other caregiver, theevent that has occurred and/or the appropriate action to take. Screenson the left of the page are directed to the caregiver, while screens onthe right side of the page are directed to the patient. FIG. 11A, forexample, illustrates the alternating screens displayed by the medicaldevice in response to the patient receiving treatment. In screen 1104,the medical device instructs the patient (and potentially anybystanders) to call the nurse or other caregiver. The screen 1104alternatives with screen 1102 notifying the nurse or other caregiverthat the patient has received treatment. It is appreciated that themedical device may display alternating screens notifying the patient tocall the nurse or other caregiver and notifying the nurse or othercaregiver that the treatment is being delayed in response to a responsebutton 210 being pushed as described above with reference to screens 910and 912 in FIG. 9A.

FIG. 11B illustrates the alternating set of screens that may bedisplayed in response to the medical device determining, for example,that one or more therapeutic shocks have been provided to the patientand the heart rhythm of the patient has failed to return to a normalrhythm. The medical device alternate between a call caregiver screen1104 and a check patient screen 1106 to indicate that the nurse or othercaregiver should check the condition of the patient.

FIG. 11C illustrates the alternating set of screens that may bedisplayed in response to the medical device detecting a devicemalfunction. For example, the medical device may perform one or moreself-tests of various internal components and determine that one or morecomponents have failed the self-test. The medical device may alternatebetween a call caregiver screen 1104 and a device malfunction screen1108. In some implementations, the medical device may identify theparticular device malfunction detected to help the nurse or othercaregiver troubleshoot the problem with the medical device.

In some examples, the medical device may issue an alert (e.g., via thebase station) each time the call caregiver screen 1104 is displayed. Forexample, the medical device may issue an alert to a nursing stationincluding an indication of issue and/or the location of the patient(e.g., room number). The alert may also indicate a degree of urgency ofthe issue. For example, the alert may indicate that the issue is veryurgent when a patient arrhythmia is detected and less urgent when aminor malfunction of the medical device is detected.

The medical device may track the alerts issued and allow a caregiver tosilence one or more alerts. As noted above, for example, the caregivermay be permitted to silence the alert only after entering his/hersecurity credentials. The alerts may be tracked locally by the medicaldevice and/or sent to a remote server to be tracked for later access byvarious medical personnel. FIGS. 12A and 12B illustrate an example setof screens to allow a caregiver to view the alert history and silence atreatment notification on the medical device.

Referring to FIG. 12A, the home screen 1202 adds an indication of arecent alert 1212 to previous home screens described above (e.g., homescreen 702 in FIGS. 7A-7D) responsive to the medical device issuing analert. The medical device may provide access to a caregiver menu inscreen 1206 to view the alert history and/or silence a treatmentnotification responsive to receiving an appropriate caregiver passwordin screen 1204. The caregiver menu in screen 1206 includes an alerthistory button 1214 and a silence treatment notification button 1216.The medical device transitions to screen 1208 responsive to activationof the alert history button 1214 and the medical device having one ormore alerts stored in memory. Screen 1208 provides an indication of thevarious alerts to the caregiver. If the medical device does not have anyalerts stored in the history, the medical device proceeds to screen 1210and displayed a notification that there are no alerts in the history.

In FIG. 12B, first three screens 1202, 1204, and 1206 are similar to thescreens with like reference numbers in FIG. 12A. FIG. 12B illustratesthe sequence of screens responsive to the silence treatment notificationbutton 1216 being activated (as opposed to the alert history button1214) where the medical device transitions to screens 1211. In theexample implementation of FIG. 12B, screen 1211 requires the caregiverto re-enter his/her security credential, and screen 1215 provides anotification to the caregiver that the notification may be silenced oncethe OK button 1218 is activated.

Service Device Alerts

Personnel in a busy health care facility may not know when a deviceneeds to be serviced, or when to return a device to a service technicianfor tests/updates and/or other servicing needs. For example, it may bedesirable that the medical device be serviced at periodic orsubstantially periodic points in time, or sent to a service center forsuch servicing. For instance, the device may track an amount of timesince the device was last serviced in the form of a service clock. Whenthe device reaches a predetermined service time threshold, for example,the device can issue a service reminder notification. For example, thepredetermined service time threshold can be preconfigured to a defaultvalue of 6 months. In some implementations, after the device has beenserviced a certain amount of times (e.g., at least 6 times), thepredetermined default value may be automatically changed to a shorter orlonger period of time (e.g., 9 months). Further, after performingservice on the device, the service technician may access a device screento reset the service reminder notification thus resetting the serviceclock. In some examples, the predetermined service time threshold may bemanually set to a different value by an authorized user as depicted inFIG. 13.

As shown in FIG. 13, in some implementations, a service menu may beaccessed. For example, the service menu may be accessed via a servicemenu button 1320 accessed via a home screen 1302. In some examples, theservice menu may be accessed by a preconfigured unique user input, e.g.,pressing and releasing one or more response buttons a predeterminedamount of times (e.g., 10 times) in successive intervals not exceeding apreset threshold (e.g., 1 second), or pressing and holding one or moreof the buttons a predetermined amount of time (e.g., 30 seconds). Othermanner of input may also be provided for accessing the service menu.

In some examples, prior to providing access to the service menu thedevice may prompt the user to enter a enter service password on servicepassword screen 1304, and provide an area 1322 for password entry and acorresponding keypad 1324. When the service menu 1306 is displayed, theuser can perform one or more software service actions, e.g., by pressingthe initiate device service 1326 button.

In some examples, the user can reset the service reminder by pressingthe reset service reminder button 1328. The user may be prompted tore-enter his/her password on screen 1308 prior to accessing screen 1310to reset the service reminder. In some implementations, the user maywish to change a service period for when the device needs to be nextserviced. For example, the device may need to be serviced every 6 monthsand as such a default service period can be 6 months. However, after acertain number of servicing events, the user may set the service periodto a shorter or longer period of time, e.g., 9 months.

Each of the processes and/or sequence of screens disclosed hereindepicts one particular sequence of acts or screens in a particularexample. The acts and/or screens included in each of these processesand/or sequences of screens may be performed by, or using, a medicaldevice specially configured as discussed herein. Some acts and/orscreens are optional and, as such, may be omitted in accord with one ormore examples. Additionally, the order of acts and/or screens can bealtered, or other acts can be added, without departing from the scope ofthe systems and methods discussed herein.

The examples of the methods and apparatuses discussed herein are notlimited in application to the details of construction and thearrangement of components set forth in the above description orillustrated in the accompanying drawings. The methods and apparatusesare capable of implementation in other examples and of being practicedor of being carried out in various ways. Examples of specificimplementations are provided herein for illustrative purposes only andare not intended to be limiting. In particular, acts, elements andfeatures discussed in connection with any one or more examples are notintended to be excluded from a similar role in any other examples.

As noted herein, the external medical device can be used in conjunctionwith a patient in a health care facility environment or setting. Forinstance, such environments can include those where a patient is beingcared for including hospices, elder care facilities, assisted livingfacilities, long term care facilities, rehabilitation centers,healthcare clinics, mobile clinics, emergency response vehicles, andoutpatient medical clinics. Further, the device as described herein canbe used in any setting/environment where such devices may be used suchas within office spaces and buildings, public areas and buildings,personal home settings, and private business areas and buildings.Moreover, in various implementations, the external medical device may beused on an outpatient basis, e.g., in connection with patients that areat home or are performing their everyday activities at home, work, orelsewhere. In some cases, the external medical device can be used inconjunction with a patient receiving at-home medical care.

In implementations where example numerical values are provided (e.g., asa predetermined numerical value), it should be understood that suchvalues can be set through one or more user-configurable parameters. Forexample, the example numerical value can be provided as a default value,and a technician or a caregiver (such as a nurse or physician) canmodify the values in accordance with the principles described hereinthrough a user interface.

Having thus described several aspects of at least one example of thisdisclosure, it is to be appreciated various alterations, modifications,and improvements will readily occur to those skilled in the art. Suchalterations, modifications, and improvements are intended to be part ofthis disclosure, and are intended to be within the scope of thedisclosure. Accordingly, the foregoing description and drawings are byway of example only.

What is claimed is:
 1. An external wearable medical device comprising:at least one electrode configured to detect cardiac activity of apatient; at least one therapy electrode configured to provide a therapyto the patient in response to detecting an arrhythmia event in thepatient based at least in part on the detected cardiac activity; agraphical user interface display disposed on the external wearablemedical device and comprising at least one caregiver interface and atleast one patient interface; and at least one processor in communicationwith the graphical user interface display, wherein the at least oneprocessor is configured to provide a first set of information to the atleast one caregiver interface, wherein the first set of informationcomprises information for operating the external wearable medical devicein conjunction with the patient and an alert history of the wearablemedical device including an indication of one or more detectedarrhythmia events in the patient, provide a second set of information tothe at least one patient interface, wherein the second set ofinformation comprises information for allowing the patient to cause theexternal wearable medical device to suspend providing the therapy to thepatient, and wherein the second set of information further comprises adirection to the patient to contact a caregiver responsive to detectingan event affecting at least one of the external wearable medical deviceand the patient, and responsive to detecting the event affecting atleast one of the external wearable medical device and the patient,automatically transmitting a notification of the event to an externalentity.
 2. The external wearable medical device of claim 1, wherein theexternal entity is a caregiver station monitoring a condition of thepatient.
 3. The external wearable medical device of claim 1, wherein theexternal entity is a base station configured to issue alerts to medicalpersonnel.
 4. The external wearable medical device of claim 1, whereinthe notification of the event includes an indication of at least one ofa type of event, a location of the patient, and an urgency of the event.5. The external wearable medical device of claim 1, wherein the eventaffecting at least one of the external wearable medical device and thepatient includes at least one of electrode falloff, excessive noise, andlow battery.
 6. The external wearable medical device of claim 1, whereinthe event affecting at least one of the external wearable medical deviceand the patient comprises the detected arrhythmia event in the patient.7. The external wearable medical device of claim 6, wherein the detectedarrhythmia event comprises at least one of a ventricular tachycardiaevent, a ventricular fibrillation event, a bradycardia event, and anatrial fibrillation event.
 8. The external wearable medical device ofclaim 1, wherein the graphical user interface display further comprisesat least one service interface, wherein the at least one processor isfurther configured to provide a third set of information to the at leastone service interface, wherein the third set of information comprisesinformation for allowing a service technician to access device settingsnot accessible by the patient.
 9. The external wearable medical deviceof claim 1, wherein the information for operating the external wearablemedical device comprises at least one training module.
 10. The externalwearable medical device of claim 9, wherein the at least one trainingmodule comprises at least one of a patient training module and acaregiver training module.
 11. The external wearable medical device ofclaim 9, wherein the at least one training module comprises a responsebutton training module, a garment training module, and a device actiontraining module.
 12. The external wearable medical device of claim 9,wherein the first set of information comprises at least one of adirection to a caregiver to administer the at least one training moduleto the patient and a direction to the caregiver to review the at leastone training module.
 13. The external wearable medical device of claim1, wherein the at least one processor is configured to provide access toa user with a caregiver level access to modify a treatment protocol ofthe patient.
 14. The external wearable medical device of claim 1,wherein the at least one processor is configured to provide access to auser with patient level access to a limited set of allowed interactions.15. A method of operating an external wearable medical devicecomprising: monitoring ECG information of a patient, the ECG informationobtained from at least one ECG sensing electrode of the externalwearable medical device; providing, on a graphical user interfacedisplay disposed on the external wearable medical device, a first set ofinformation in at least one caregiver interface, wherein the first setof information comprises information for operating the external wearablemedical device in conjunction with the patient and an alert history ofthe external wearable medical device including an indication of anydetected arrhythmia event in the patient, providing, on the graphicaluser interface, a second set of information in at least one patientinterface, wherein the second set of information comprises informationfor allowing the patient to cause the external wearable medical deviceto suspend providing a therapy to the patient, and wherein the secondset of information further comprises a direction to the patient tocontact a caregiver responsive to detecting an event affecting at leastone of the external wearable medical device and the patient, andresponsive to detecting the event affecting at least one of the externalwearable medical device and the patient, automatically transmitting anotification of the event to an external entity.
 16. The method of claim15, wherein the notification of the event includes an indication of atleast one of a type of event, a location of the patient, and an urgencyof the event.
 17. The method of claim 15, wherein the event affecting atleast one of the external wearable medical device and the patientincludes at least one of electrode falloff, excessive noise, and lowbattery.
 18. The method of claim 15, wherein the event affecting atleast one of the external wearable medical device and the patientcomprises the detected arrhythmia event in the patient.
 19. The methodof claim 18, wherein the detected arrhythmia event comprises at leastone of a ventricular tachycardia event, a ventricular fibrillationevent, a bradycardia event, and an atrial fibrillation event.
 20. Themethod of claim 15, wherein the external entity is a caregiver stationmonitoring a condition of the patient.